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Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

Primary Purpose

Pancreatic Cancer Stage IV

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine

Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

Cabiralizumab

About this trial

This is an interventional treatment trial for Pancreatic Cancer Stage IV focused on measuring Pancreating Cancer, Cancer, Stage IV, gemcitabine, nivolumab, cabiralizumab, BMS-986227, FPA008, GemCaN, Stand Up to Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis
Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment.

Measurable disease by RECIST 1.1.

Demonstrate adequate organ function

Normal Vitamin D level.

Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy.

Exclusion Criteria:

Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment.
Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients.
Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
Evidence of central nervous system (CNS) metastasis
Participants with active, known, or suspected autoimmune disease.
Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
Uncontrolled or significant cardiovascular disease
Prior organ allograft or allogeneic bone marrow transplantation.
Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
Evidence of coagulopathy or bleeding diathesis.
Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.

Sites / Locations

UCSD Moores Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gemcitabine +nivolumab + cabiralizumab

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)

To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1

Secondary Outcome Measures

Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria

Overall Survival (OS)

Full Information

NCT ID

NCT03697564

First Posted

September 28, 2018

Last Updated

April 27, 2023

Sponsor

Hitendra Patel

Collaborators

Stand Up To Cancer, Lustgarten Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03697564

Brief Title

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

Official Title

Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Suspended

Why Stopped

Working on getting accurate information for patients interested in the study.

Study Start Date

October 31, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hitendra Patel

Collaborators

Stand Up To Cancer, Lustgarten Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone. Cabiralizumab is an antibody (a type of protein) that binds to a molecule called CSF-1r. CSF-1r is a molecule present on different types of cells in your immune system that controls parts of your immune system. Blocking CSF-lr could potentially stop the cancer cells which it appears on from escaping the immune system, which could then act to kill the cancer cells. Nivolumab is an anti-PD-1 antibody that boost the body's immune system. It works by attaching to and blocking a molecule on white blood cells called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Gemcitabine is currently used to treat advanced or metastasized (spread) pancreatic cancer. It is used in patients whose disease cannot be removed by surgery and who have already been treated with other chemotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer Stage IV

Keywords

Pancreating Cancer, Cancer, Stage IV, gemcitabine, nivolumab, cabiralizumab, BMS-986227, FPA008, GemCaN, Stand Up to Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

gemcitabine +nivolumab + cabiralizumab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

1000 mg/m2 IV on days 1, 8, and 15 Q4W

Intervention Type

Drug

Intervention Name(s)

Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

Other Intervention Name(s)

Opdivo

Intervention Description

480mg IV on Day 1 Q4W

Intervention Type

Drug

Intervention Name(s)

Cabiralizumab

Intervention Description

4mg/kg IV on day 1 and 15 Q4W

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria

Time Frame

6 months

Title

Overall Survival (OS)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment. Measurable disease by RECIST 1.1. Demonstrate adequate organ function Normal Vitamin D level. Able to submit an archival tumor specimen (primary or metastatic site). Patients with cytology only that do not have adequate archived tumor specimen available, will require a baseline biopsy. Exclusion Criteria: Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment. Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients. Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period. Evidence of central nervous system (CNS) metastasis Participants with active, known, or suspected autoimmune disease. Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels. Uncontrolled or significant cardiovascular disease Prior organ allograft or allogeneic bone marrow transplantation. Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis. Evidence of coagulopathy or bleeding diathesis. Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hitendra Patel, MD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrew Lowy, MD

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCSD Moores Cancer Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

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